Burn and wound ointment

ABSTRACT

This invention refers to the sphere of medicine, in particular to pharmaceutics and concerns the preparations for burn treatment. The technical result of the present invention is in widening the assortment of medicinal preparations for treatment of bums and wounds, in increasing treatment effect. The ointment contains the components in the following relation of mass parts: 
     
         ______________________________________                                    
 
    
     celandine      Chelidonium majus                                          
                             15-25 g                                      
plantain               Plantago major                                     
                                     15-25 g                              
matricary             Matricaria chamomilla                               
                              15-25 g                                     
yarrow                   Achillea millefolium                             
                               15-25 g                                    
calendula             Calendula officinalis                               
                              15-25 g                                     
St. John&#39;s-wort                                                           
               Hypericum perforatum                                       
                               15-25 g                                    
gum-tree               Eucalyptus globulus                                
                                15-25 g                                   
olive oil             Oleum olivarum                                      
                                     1000 g                               
yellow wax of honey                                                       
               Cera flava                80-130 g                         
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This application is a 371 of PCT/GE97/00001 filed May 8, 1997.

This invention refers to the sphere of medicine, in particular topharmaceutics and concerns the preparations for bum treatment.

There is known calendula ointment Unguentum "Calendula", which containstincture of calendula (on 70% spirit 1:10)--20 g, vaseline--90 g:[Mashkovskij M. V. "Medicinal Means", Moscow, "Medicine" 1986, vol. 2,p. 2.424].

At using this ointment on wound and burn the process of healing isslowed down, as the ointment contains only one medicinal preparation andvaseline. vaseliine makes crust on the injured surface, under which themicrobes are easily reproduced.

There is also known "Ointment Kolkhuri", which contains St.John's-wort.the oak bark, haw-thom, yarrow, yellow melilot, horse-chestnut0.06-0.065 in equal quanity, nettle 0.10-0.11, gum-tree extract 0.02,belladonna extract 0.02, vaseline--the rest; [GE 13, Darsania, V.15.05.94].

This ointment is used as analgetic and antiinflammatory means and isless effective for healing the wounds and burns, as haw-thorn andbelladonna arc not characterized by antiinflammatory and regenerationstimulating effect. The yellow melilot and horse-chestnut containsubstances which hinder the blood coagulation and do not effect the skinregeneration. The oak bark and nettle have antiinflammatory properties,but it must be mentioned, that tannin involved in oak bark in reactionwith the injured surface mucous membrane proteins at burn makes a coat,under which purulent process occurs. The nettle increases the quantityof erythrocytes and hemoglobin, which is raised at burn in result ofintensified loss of plasma.

The technical result of the present invention is in widening theassortment of medicinal preparations for treatment of burns and wounds,in increasing treatment effect.

The technical result is achieved by that the green ointment, whichcontains St.John's-wort, yarrow, gum-tree, additionally containscelandine, plantain, matricary, calendula, olive oil and yellow wax ofhoney in the following relation of components in mass parts:

    ______________________________________                                        celandine      Chelidonium majus                                                                           15-25 g                                          plantain               Plantago major                                                                              15-25 g                                  matricary             Matricaria chamomilla                                                                 15-25 g                                         yarrow                   Achillea millefolium                                                                15-25 g                                        calendula             Calendula officinalis                                                                 15-25 g                                         St. John's-wort                                                                              Hypericum perforatum                                                                          15-25 g                                        gum-tree               Eucalyptus globulus                                                                    15-25 g                                       olive oil             Oleum olivarum                                                                               1000 g                                   yellow wax of honey                                                                          Cera flava                80-130 g                             ______________________________________                                    

The additional application of celandine, plantain, matricary, calendula,olive oil and yellow wax of honey in the ointment in the said relationof components in mass parts enables to increase treatment effect, whichis provided by the properties of the grass.

Celaudine--is characterized by antiinflammatory, local analgetic,regeneration accelerating effect.

Plantain--is characterized by antimicrobic, hemostasia and wound healingeffect.

Matricary--is characterized by antiseptic, local analgetic andantiinflammatory effect, accelerates regeneration.

Calendula--strengthens the circulatory vessels walls, reduces theirpermeability, what is very important at burn, when the capillaryconduction and plasinorrhea is increased. Calendula's effect grows incombination with matricary and yarrow, skin epitalization andgranulation, local protective mechanisms increase.

Olive oil--has deeper effect than the vaseline, the skin absorbs iteasily.

Honey wax--contains large quantity of vitamin A, which is necessary, forrecovery of skin entirety and provides for fast healing of the burn.

Besides, the increase of the quantify of celandine, plantain, matricary,calendula. yarrow, St.John's-wort, gum-tree in green ointment more than25 g, of the olive oil more than 1000 g and of the honey yellow wax morethan 130 g doesn't promote the treatment efficiency and results inover-expenditure of the raw.

At the same time the reduction of the quantity of celandine, plantain,matricary, calendula, yarrow, St.John's-wort, gum-tree below 15 g, ofthe olive oil below 1000 g and of the honey yellow wax below 80 gincreases the time of treatment and reduces its efficiency.

Method for preparing of green ointment is carried out in the followingway:

small grinded grass--15-25 g of celandine, 15-25 g of plantain, 15-25 gof matricary, 15-25 g of calendula, 15-25 g of yarrow, 15-25 g ofSt.John's-wort, 15-25 g of gum-tree is filled in enamel vessel, 1000 gof olive oil is poured in and boiled on water bath during 6 hours,cooled to room temperature and pressed out.

The obtained oil mass of 700-900 g is boiled again on water bath andmixed with small cut honey wax Of 80-130 g. boiled for 30 minutes, putaway and stirred until cooling to room temperature.

EXAMPLE 1

Small grinded dried grass--15 g of calendine, 15 g of plantain, 15 g ofmatricary, 15 g of calendula, 15 g of yarrow, 15 g of St.John's wort, 15g of gum-tree is filled in enamel vessel, 1000 g of olive oil is pouredin and boiled on water bath during 6 hours, cooled to room temperatureand pressed out. The obtained oil mass of 900 g is boiled again on waterbath and mixed with small cut 105 g honey wax, boiled for 30 minutes,put away and stirred until cooling to room temperature.

EXAMPLE 2

Small grinded dried grass--20 g of calendine, 20 g of plantain, 20 g ofmatricary, 20 g of calendula, 20 g of yarrow, 20 g of St.John's wort, 20g of gum-tree is filled in enamel vessel, 1000 g of olive oil is pouredin and boiled on water bath during 6 hours, cooled to room temperatureand pressed out. The obtained oil mass of 800 g is boiled again on waterbath and mixed with small cut 105 g honey wax, boiled for 30 minutes,put away and stirred until cooling to room temperature.

EXAMPLE 3

Small grinded dried grass--25 g of calendine, 25 g of plantain, 25 g ofmatricary, 25 g of calendula, 25 g of yarrow, 25 g of St.John's-wort, 25g of gum-tree is filled in enamel vessel, 1000 g of olive oil is pouredin and boiled on water bath during 6 hours, cooled to room temperatureand pressed out. The obtained oil mass of 700 g is boiled again on waterbath and mixed with small cut 130 g honey wax, boiled for 30 minutes,put away and stirred until cooling to room temperature.

According to said examples the ointment was applied on the members ofthe inventor's family and volunteers at treatment of I, II, III degreeburns, of lacerated, contused, incised wounds. At applying the bandage,with patients there was marked--arrest of bleeding, reduction of pain,stoppage of purulent discharge, acceleration of granulation andepithelization. There were not cases of treatment complication, such assuppuration, bleeding, occurrence of the thick coat on the surface,prolongation of wound healing. The ointment effect was marked at theburn of III degree, when all the sources for epithelium reproduction inthe injured area needed for skin regeneration are destroyed.

1. Patient E.D.--woman, 36 years old, resident of Tbilisi, Marjanishvilistr. 46.

Diagnosis: burn of III degree.

There was burned more than 50% of body surface, after treatment in thehospital during 3 months flection surface of the right hand from armpitto hand and chest was left unhealed. The only way for healing the woundwas skin transplantation, which the patient categorically refused anddecided to begin treatment with green ointment. Objectively the musclelayer was injured on different depth, there was marked bleeding, violentpain, swelling of the tissues around. In several minutes after applyingthe ointment the patient felt easing of tension, pain, arrest ofbleeding. The ointment was applied every day during a month, graduallyin the injured area skin tubercles occurred, the granulation tissue grewintensively without suppuration and coating. The wound was healed in amonth without scars.

2. Patient Sh.N.--woman, 44 years old, resident of Tbilisi.

Diagnosis: burn of II degree. The hand was injured, was marked violentredness with different quantity of vesicles with serous exudates. Theointment was applied 2 times a day during 10 days. The injury healedwithout suppuration.

3. Patient T.B. child, 3 years old, resident of Tbilisi.

Diagnosis: lacerated wound.

The child's hand was lacerated with obtuse subject, the wound was notsutured, in three days after applying the ointment the wound was filledwithout scars.

4. Patient Z.N.--woman, 71 years old. resident of Tbilisi.

Diagnosis: burn of II degree.

With the patient there was marked redness of lower extremities, vesiclesof different sizes filled with liquid. The ointment was applied everyday during 3 weeks. The injury healed without scars.

5. Patient I.I.--man, 57 years old, resident of Tbilisi.

Diagnosis: lacerated wound.

The patient's hand was lacerated deeply with an obtuse subject. Thewound was not sutured. the ointment was applied every day during oneweek. The wound healed without scars.

The pre-clinical investigations of the new medicinal means greenointment were carried out in the Institute for Experimental and ClinicalMedicine of Tbilisi State University by GLP Program "The rules ofPre-Clinical Estimation of Pharmacological Means", RD 64-126-91, Moscow1992.

The mechanism of action of the green ointment on the body was studied bytoxicological, microbiological, morphological, immunological,pathophysiological, histostructural, biochemical methods.

Green ointment is non-toxic. Its LD₅₀ is more than 320-fold therapeuticdose, which is equal to 9152.0 mg/kg. green ointment is notcharacterized by cumulative properties. Cumulation LD₅₀ is more than960-fold therapeutic dose, which is equal to 27456.0 mg/kg. The ointmentis not characterized by allergic or local-irritation action.

The results of the investigations enable to consider green ointment asharmless and safe for human health.

By bacteriological investigations it was stated that green ointment hasbactericidal effect with the microbes of the following groups:Staphylococcus epidermidis, Streptococcus fecalis, Psevdomonasaeruginosa, Escherichia coli.

For the experiment was made the model of III degree burn on rabbits. Theexperimental group was treated with green ointment, the control groupwith 5% liniment of synthomycin.

By means of electric-paramagnetic resonance were examined the skin,liver, spleen, glands above kidneys and blood of experimental andcontrol animals. In result of green ointment's effect the intensity ofribonucleotide-reductase, which indicates the growth of proliferationprocesses in spleen, was increased by 90% in comparison with controldata. We can say that green ointment is an inductor ofribonucleotide-reductase.

Under the action of green ointment the intensity of nonhemic ironnitrizil complexes signal g=2.03, which testifies the reduction of afterburn hypoxia degree in liver as well of methemoglobin and intensity ofsignals of Mn²⁺ containing complexes, that is the indicative ofhemolysis intensity and preservation of membrane structure enterity. Itcan be said that green ointment is characterized with membraneprotective properties, which is determined by the reduction of lipidesperoxide oxidation intensity. The indicative of membrane stabilizingeffect is the reduction of oxidized ccruloplasmin signal and increase ofFe³⁺ transferrin signal intensity in comparison with control data.

According to the results of the investigations carried out by means ofelectric-paramagnetic resonance method, green ointment reduces theintensity of lipides peroxide oxidation in cells, promotes forpreservation of the enterity of membrane structure, reduces hypoxiadegree in liver, effects proliferation processes and is an inductor ofribonucleotide-reductase.

The results of investigations show that under the effect of greenointment with experimental rabbits the primary-coat is removed earlier,than with the control animals, in result the healing processaccelerated. The remove of the coat and healing acceleration makes42.31% in comparison with 5% liniment of synthomycin. At the same timeunder the effect of green ointment the inflammatory processes incirculatory vessels is less expressed, microcirculation is notdisrupted, thrombosis and stasis are not marked in the tissues aroundthe wound. The widened capillaries refer to plasma capillaries, andthat's why around the wound insignificant cell infiltration of bloodelements is marked. These cell elements refer to the cells of tissueorigin.

The comparison of healing rate and control rabbits shows, that healingacceleration in experimental animals is promoted by sharp activation ofcell-tissue elements, increase of phagocytosis, increase of antioxidantactivity of blood and tissues. The increase of phagocytosis andantioxidant activity of tissues causes the limitation of secondaryalteration, the degradation of inflammatory process modulators andmediators activity, death of microorganisms.

It must be mentioned, that under the effect of green ointment theproliferation processes of connective tissues and epithelium elementsare carried out simultaneously.

Under the effect of green ointment the immune cell circle is activated,the quantity of T lymphocytes is increased, the phagocytosis process isaccelerated.

The application of present ointment enables:

widening of the assortment of medicinal preparations for burns andwounds;

increase of the treatment efficiency approximately for 42%.

The clinical approbation of green ointment was carried out in 6 clinicson 449 patients with different diagnosis. Among them, with infected anduninfected wounds --158 patients, with bum disease--75, with purulentdamages of hypodermic tissues (carbuncle, furuncle, panaritium, abscess,phlegmon)--26, with trophic ulcers of different etiology--60, withcervical erosion and colpitis--130 patients.

The efficiency of green ointment action was evaluated by followingcriteria: general condition of a patient, visual evaluation ofregeneration changes, epitalization terms of wound, ulcer and erosionsurfaces, bacteriologic, cytological and colposcopy examinations.

The held examinations showed, that the application of green ointment attreatment of mentioned diseases causes the stimulation of regenerationprocesses, fast healing, the wounds are healed earlier than classicterms.

At treatment period there was observed the fast decrease of the purulentdischarge, ache and edema of tissues around the wound, significantacceleration of wound clearing, improvement of microcirculation, theacceleration of peripheral epitalization processes.

At burn disease of I, II and III degrees with the patients there wasobserved the decrease and elimination of ache and plasmorrhea. Thetreatment results in complete epitalization without scars.

At treatment of acute colpitis the efficiency of ointment action wasstipulated by its bactericidal action. After treatment in neither casesthere was observed the increase of pathological microbes, the completerecovery of a patient takes place.

At cervical erosion the acceleration of epitalization processes, therecovery of mucous membrane takes place more faster than at treatmentwith other preparations.

At applying of green ointment there was no case of prolongation andcomplication of the disease.

On the basis of conducted investigations the green ointment isrecommended by Pharmacological Committee as an effective medicinal meansstimulating regeneration.

We claim:
 1. An ointment for the treatment of burns and wounds inmammals, which comprises:

    ______________________________________                                        Chelidonium majus     15-25 g;                                                Plantago major                15-25 g;                                        Matricaria chamomilla  15-25 g;                                               Achillea millefolium    15-25 g;                                              Calendula officinalis  15-25 g;                                               Hypericum perforatum    15-25 g;                                              Eucalyptus globulus      15-25 g;                                             Oleum olivarum                1000 g; and                                     Cera flava                        80-130 g.                                   ______________________________________                                    


2. A method for the treatment of burns and wounds in mammals, whichcomprises:applying to the site of a burn or a wound a burn-healing or awound-healing effective amount of an ointment comprising Chelidoniummajus 15-25 g; Plantago major 15-25 g; Matricaria chamomilla 15-25 g;Achillea millefolium 15-25 g; Calendula officinalis 15-25 g; Hypericumperforatum 15-25 g; Eucalyptus globulus 15-25 g; Oleum olivarum 1000 gand Cera flava 80-130 g.